Clostridium Difficile InfectionPhase 2NCT03643887
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
A Phase 2 study testing FMT Capsule DE in people with Clostridium Difficile Infection, run by University of Wisconsin, Madison.
Trial summary
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- FMT Capsule DE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitively intact and willing to provide informed consent
- Willing and able to comply with all study procedures for the duration of the study
- Age 18 years or older
- Two positive stool cultures for CRE or VRE (positive for the same organism on both cultures). The most recent stool culture must be within 14 days of randomization.
- Women of childbearing potential in a sexual relationship with men must use an acceptable method of contraception (including, but not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception started at least 30 days before enrollment into the study, or intercourse with men who underwent a vasectomy) for 4 weeks following completion of the study treatment.
- Males must agree to avoid impregnation of women during and for 4 weeks following completion of the study treatment through the use of an acceptable method of contraception (including but not limited to, barrier with additional spermicidal foam or jelly or vasectomy).
- Able to take the test capsule successfully with no signs or symptoms of dysphagia.
Who cannot join
- Admitted to an intensive care unit (ICU) for medical reasons (not just boarding).
- Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
- Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks.
- Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
- Previous FMT or microbiome-based products in the last 90 days.
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- Active antibiotic-resistant bacteria (ARB) or gastrointestinal infection at time of enrollment.
- Any other gastrointestinal illness including diarrhea.
- Known or suspected toxic megacolon and or known small bowel ileus.
- Bowel obstruction or other gut motility issues as noted by the patient or in the electronic medical record.
- Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment not including appendectomy or cholecystectomy.
- History of total colectomy or bariatric surgery.
- Concurrent intensive induction chemotherapy, radiation therapy, or biologic treatment for an active malignancy. Patients on maintenance chemotherapy may be enrolled after consultation with the medical monitor.
- Patients with severe anaphylactic or anaphylactoid food allergy.
- Solid organ transplant recipients ≤90 days post-transplant or on active treatment for rejection.
- Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-tumor necrosis factor (anti-TNF) will be permitted. Participants taking glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine, methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine) and mycophenolate mofetil may be enrolled only after consultation with the medical monitor.
- If At risk of CMV/EBV associated disease (at discretion of investigators, e.g. immunocompromised participant), negative Immunoglobulin G (IgG) testing for cytomegalovirus (CMV) or Epstein Barr Virus (EBV).
- Cognitive impairment at the time of enrollment.
- Expected life expectancy <6 months.
- Inability (e.g. dysphagia) to or unwilling to swallow capsules.
- Unable or unwilling to comply with protocol requirements.
- Any condition that would jeopardize the safety or rights of the patient, would make it unlikely for the patient to complete the study, or would confound the results of the study.
- Females who are pregnant, lactating, or planning to become pregnant during the study.
- Female patients of childbearing potential will take a pregnancy test and be excluded if pregnant.
About this study
Official title: A Phase II Randomized, Double-blind Placebo-controlled Trial of Fecal Microbiota Transplantation for Vancomycin-resistant Enterococcus and Carbapenem-resistant Enterobacteriaceae
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health. Healthcare-associated infections (HAIs) like VRE and CRE lengthen the duration of a hospital stay, increase the cost of hospitalization, and increase mortality. Because colonization precedes infection, prevention or treatment of VRE/CRE colonization is essential. We propose a treatment approach to promote gut decolonization by VRE and CRE without using antibiotics. Participants enrolled in this study will be randomized a one-time dose of either study drug or placebo, will be followed for 6 months, and will submit stool samples for analysis of several outcomes for the trial.
Read the detailed description
This is a phase II, double-blind, randomized, placebo controlled trial assessing the effects of one-time oral FMT on the composition and function of the gut microbiome compared to placebo in a population of patients with baseline CRE or VRE gut colonization. Participants will be adults who have had two consecutive positive stool cultures for VRE or CRE and meet all inclusion/exclusion criteria. Patients (N=90) will be randomized at a 1:1 ratio. Randomization will be double-blinded. Each subject will be followed for 6 months. Stool samples will be taken at baseline and from subjects weekly for 4 weeks, then every 4 weeks for 8 weeks, then at 6 months regardless of treatment group. All patients will be asked to complete a stool diary
- Conditions
- Clostridium Difficile Infection
- Being tested
- FMT Capsule DE, Placebo oral capsule
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT Capsule DEDrug
30 capsule one-time oral dose
Placebo oral capsuleDrug
Also called Placebo
30 capsule one-time oral dose
| Study group | Role | What they receive |
|---|---|---|
| FMT Capsule DE | Experimental | FMT Capsule DE Receives: Drug: FMT Capsule DE |
| Placebo Oral Capsule | Placebo comparator | Placebo Capsule Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo
VRE/CRE decolonization is defined by absence of VRE/CRE on stool culture using standard laboratory techniques.
Measured: 6 months
Secondary outcomes (5)
VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization.
VRE/CRE infection will be defined as an associated bacteremia, urinary tract infection, or would-related infection.
Measured: 1 month
Microbial engraftment assessed by microbial disruption index (MDI) at Day 3, Day 10, and Week 4 following randomization
VRE/CRE type and strain level engraftment, using whole genome sequencing laboratory techniques
Measured: 1 month
Antibiotic resistant bacteria (ARB) decolonization at Day 10 after randomization.
ARB testing will be done with Acuitas (OpGen) MDRO test or a similar platform
Measured: 10 days
Antibiotic resistant bacteria (ARB) infection at Day 3, Day 10, Week 4 after randomization, and time to infection if ARB infection occurs
ARB infection will be defined as extended spectrum beta lactamase clinical infection.
Measured: 1 month
Adverse events/serious adverse events through Day 10, Week 4, and Month 6 following randomization.
Safety of FMT Capsule DE compared to placebo. Incidence of newly acquired transmissible infectious diseases that are considered adverse events of special interest (AESI).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: No funding obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD PhD, Principal investigator, Infectious Disease, School of Medicine & Public Health, University of Wisconsin-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643887
- Sponsor's protocol ID
- W81XWH18PRMPCTA
- Status last verified
- Jun 2020
- First submitted
- 21 Aug 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind Placebo-controlled Trial of Fecal Microbiota Transplantation for Vancomycin-resistant Enterococcus and Carbapenem-resistant Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT03643887
- Acronym / sponsor ID
- W81XWH18PRMPCTA
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health. Healthcare-associated infections (HAIs) like VRE and CRE lengthen the duration of a hospital stay, increase the cost of hospitalization, and increase mortality. Because colonization precedes infection, prevention or treatment of VRE/CRE colonization is essential. We propose a treatment approach to promote gut decolonization by VRE and CRE without using antibiotics. Participants enrolled in this study will be randomized a one-time dose of either study drug or placebo, will be followed for 6 months, and will submit stool samples for analysis of several outcomes for the trial.
Detailed description
This is a phase II, double-blind, randomized, placebo controlled trial assessing the effects of one-time oral FMT on the composition and function of the gut microbiome compared to placebo in a population of patients with baseline CRE or VRE gut colonization. Participants will be adults who have had two consecutive positive stool cultures for VRE or CRE and meet all inclusion/exclusion criteria. Patients (N=90) will be randomized at a 1:1 ratio. Randomization will be double-blinded. Each subject will be followed for 6 months. Stool samples will be taken at baseline and from subjects weekly for 4 weeks, then every 4 weeks for 8 weeks, then at 6 months regardless of treatment group. All patients will be asked to complete a stool diary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| FMT Capsule DE | Experimental | Drug: FMT Capsule DEFMT Capsule DE |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo Capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cognitively intact and willing to provide informed consent
- Willing and able to comply with all study procedures for the duration of the study
- Age 18 years or older
- Two positive stool cultures for CRE or VRE (positive for the same organism on both cultures). The most recent stool culture must be within 14 days of randomization.
- Women of childbearing potential in a sexual relationship with men must use an acceptable method of contraception (including, but not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception started at least 30 days before enrollment into the study, or intercourse with men who underwent a vasectomy) for 4 weeks following completion of the study treatment.
Key exclusion criteria (24 listed)
- Admitted to an intensive care unit (ICU) for medical reasons (not just boarding).
- Patients residing in a nursing home, long-term care facility or rehabilitation center may be enrolled.
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to randomization. Does not include antibiotics used for prophylaxis or topical antibiotics.
- Requires continued antibiotic use or anticipates antibiotic use in the upcoming 4 weeks.
- Unwilling to withhold probiotics for a minimum of 48 hours prior to providing a screening stool sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT Capsule DE30 capsule one-time oral dose | Drug | FMT Capsule DE |
| Placebo oral capsuleAlso: Placebo30 capsule one-time oral dose | Drug | Placebo Oral Capsule |
Primary outcome
Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo
Time frame: 6 months
VRE/CRE decolonization is defined by absence of VRE/CRE on stool culture using standard laboratory techniques.
5 secondary outcomes
VRE/CRE infection at Day 3, Day 10, and Week 4 following randomization.
Time frame: 1 month
Microbial engraftment assessed by microbial disruption index (MDI) at Day 3, Day 10, and Week 4 following randomization
Time frame: 1 month
Antibiotic resistant bacteria (ARB) decolonization at Day 10 after randomization.
Time frame: 10 days
Antibiotic resistant bacteria (ARB) infection at Day 3, Day 10, Week 4 after randomization, and time to infection if ARB infection occurs
Time frame: 1 month
Adverse events/serious adverse events through Day 10, Week 4, and Month 6 following randomization.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasia Safdar, MD PhD principal investigator
Infectious Disease, School of Medicine & Public Health, University of Wisconsin-Madison
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT Capsule DE in people with Clostridium Difficile Infection, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare incidence of VRE/CRE decolonization between FMT Capsule double encapsuled (DE) and placebo (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.